This course, a Thomson Reuters Cortellis Regulatory Online Learning module, covers how to register a pharmaceutical or medical product using the decentralised procedure. The course examines the products the procedure applies to and describes the steps for completing and submitting a marketing authorization application. The phases and key events of the evaluation process and the possible outcomes of the procedure are discussed. The course concludes by examining the tasks that occur after the decentralised procedure is finalized and the parties responsible for completing them.
Registering a pharmaceutical or medical product using the decentralised procedure
Who should attend?
Professionals and experts in the pharmaceutical, biotechnology, and medical device fields
Participants who complete this course should be able to:
- Understand to which products the decentralised procedure applies
- Clarify the aspects to consider when defining a strategy for submission
- Identify the authorities that can provide regulatory and/or scientific advice
- Understand the role the Reference Member State plays in the procedure
- Differentiate the phases of the decentralised procedure
- Review the activities involved in the procedure's timetable
- List the content of the various assessment reports
- Explore the possible outcomes of the decentralised procedure
- Examine post-authorisation activities
The module takes an average of one hour to complete.